Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency (CSMünchen01)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT01089075
First received: February 2, 2010
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after TBI or SAH on cognitive function.


Condition Intervention Phase
Partial Corticotrope Insufficiency
Drug: Hydrocortisone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage

Resource links provided by NLM:


Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • Changes in score of alertness test (TAP)- interindividual differences [ Time Frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in score of Alertness Test (TAP) - intraindividual differences [ Time Frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo) ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo/20 mg hydrocortisone
Order of study treatment: 7 days placebo followed by 7 days hydrocortisone
Drug: Hydrocortisone
20 mg po for 7 days
Other Name: Hydrocortison GALEN 20 mg
Drug: Placebo
2 tablets po
Other Name: P-Tabletten 7 mm Lichtenstein
Active Comparator: hydrocortisone/placebo
Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo
Drug: Hydrocortisone
20 mg po for 7 days
Other Name: Hydrocortison GALEN 20 mg
Drug: Placebo
2 tablets po
Other Name: P-Tabletten 7 mm Lichtenstein

Detailed Description:

This is a controlled, randomized, double-blind, placebo-controlled, crossover, interventional study. The benefit of replacement in partial corticotropic failure on brain function (cognition), especially in cases with borderline low cortisol levels after stimulation is unknown.

Moreover, since glucocorticoids might affect hGH secretion, the effect of hydrocortisone on hGH secretion reflected by IGF-1 levels will be assessed. If IGF-1 is below 2 SD at the end of the study, hGH secretion will additionally be determined by a GHRH-arginine-test.

An improved cognition in TBI and SAH patients with partial corticotropic insufficiency would give a new treatment option in this population which may lead to better quality of life and an enhanced rehabilitation process.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (male and female) between 18 and 75 years
  • 1 -12 month after TBI or SAH before prescreening
  • Cortisol level 100-180 ng/ml after stimulation with ACTH
  • Written informed consent by patient or a legally accepted representative

Exclusion Criteria:

  • Pregnancy and lactation period (during study treatment)
  • Concomitant or previous high-dose therapy with glucocorticoids; previous treatment with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 months before study participation
  • Suspected or known hypersensitivity to hydrocortisone or any of its components
  • Albumine less than 2,5 g/dl
  • Suspected or known drug or alcohol abuse
  • Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment
  • Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
  • Participation in another clinical trial with investigational new drugs
  • Severe medical or psychiatric disease
  • Change of dosage of any other drug which might influence the corticotrope axis or cognitive function (e.g. antidepressive treatment) during the last 3 weeks
  • Oral contraceptives
  • Severe disturbances in articulation, visual faculty or hearing
  • Any elective surgery or medical treatment planned in the observation period
  • Intensive Care treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089075

Locations
Germany
Neurological Clinic Bad Aibling
Bad Aibling, Bavaria, Germany, 83043
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Novo Nordisk A/S
Investigators
Study Director: Günter K. Stalla, Prof. Dr. Max-Planck-Institute, Munich
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. G. K. Stalla, Head of Department Internal Medicine/Endocrinology and Clinical Chemistry, Max-Planck-Institute for Psychiatry, Munich
ClinicalTrials.gov Identifier: NCT01089075     History of Changes
Other Study ID Numbers: 2009-014909-14
Study First Received: February 2, 2010
Last Updated: March 17, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Max-Planck-Institute of Psychiatry:
neuropsychological effects of hydrocortisone replacement

Additional relevant MeSH terms:
Adrenal Insufficiency
Addison Disease
Brain Injuries
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014